Sr QA Manager

Senior Quality Systems Manager

About the Role

The Senior Quality Systems Manager will lead and oversee quality and compliance initiatives within the region. This role ensures alignment with local regulatory requirements and global quality standards while supporting business operations.

Key Responsibilities

• Maintain and enhance the Quality Management System (QMS) to ensure compliance with global and local regulations.

• Manage internal and external audit programs to uphold effectiveness and regulatory adherence.

• Oversee the training and education program, including Learning Management Systems (LMS), to meet compliance standards.

• Ensure products and processes comply with Quality Agreements between regional and global manufacturing entities.

• Conduct compliance assessments to identify gaps and drive continuous improvement.

• Collaborate with leadership to achieve commercial and operational objectives.

• Represent the regional team in cross-functional, global projects and initiatives.

Qualifications

• Bachelor’s degree in engineering, life sciences, chemistry, or a related field.

• 10+ years of experience in the medical device, diagnostics, or pharmaceutical industry, with 5+ years in a managerial role.

• Proven experience in leading or supporting regulatory audits (e.g., ISO, health authority inspections).

• 5+ years of QMS Lead Auditor experience.

• Strong understanding of medical device regulations and guidelines.

• Ability to collaborate effectively with global and local stakeholders.

• Self-motivated with the ability to work independently in a matrixed organization.

• Language proficiency: Native in Japanese and fluent in English (written and spoken).

Company Overview

A global leader in specialty measurement technologies, the company has been at the forefront of scientific innovation for over 60 years. With a presence in 35+ countries, it serves industries such as healthcare, environmental science, food safety, and water quality.

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